The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Operation time [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]

operation time will be measured by attending nerse

Secondary Outcome Measures:

Pain sensation after surgery [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Pain score will be described daily during hospitalization, and also at out patient clinic after discharge

Recovery of bowel movement [ Time Frame: Participants will be followed the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]

Gas out is regarded as a recovery of bowel movement

Wound complication [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Blood loss during operation [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Intra-operative hemodynamic status [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Events as below will be recorded and compared severe hypertension(systolic BP>200mmHg), severe hypotension(systolic BP<90mmHg), Tachycardia(HR>110/min), Bradycardia(HR<50/min)

Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of adrenalectomy. This traditional method has been used widely because this procedure provides wide view of the whole abdomen which is familiar to surgeons. But due to its unique location at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach to kidney and adrenal gland, and so operative time can be shortened. But there has been no randomized controlled trial between these two methods.

Therefore, as experienced surgeons in both methods, we want to practice this study.

Eligibility

Ages Eligible for Study:

18 Years to 79 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients who are expected to have benign adrenal disease at preoperative exams

Patients who have pheochromocytoma measured less than 5cm, and the other benign adrenal tumors less than 7cm in diameter in preoperative CT scan

Patients who do not have previous surgery history at the interested quadrant

Patients who is I or II grade in ASA classification(American society of anesthesiologists' physical status classification)

History of coronary angioplasty or Coronary artery bypass graft surgery

History of stroke, transient ischemic attack with sequela

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676025

Locations

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Kyueun Lee, Ph.D

Seoul National University Hospital

More Information

Responsible Party:

Kyu Eun Lee, Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea, Seoul National University Hospital